Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT04979130
- Phase
- PHASE4
- Status
- Completed
Conditions
- Chronic Inflammation
- Intestinal Permeability
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide — DRUGSemaglutide 1.34 mg/mL solution for injection in 1.5 mL pre-filled PDS290 pen-injector provided by Novo Nordisk.
- Placebo — DRUGSemaglutide placebo, solution for injection, 1.5 mL pre-filled PDS290 pen-injector provided by Novo Nordisk.
Study Details
This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.
Key Dates
- Start date
- Jan 1, 2022
- Status verified
- Mar 2025
- Primary completion
- Oct 16, 2024
- Completion
- Oct 16, 2024
Study Design
- Enrollment
- 69 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: SC semaglutideParticipants receive a once weekly, subcutaneous, Semaglutide injection for 16 weeks in addition to the participants background metformin monotherapy. The participants in this arm will begin at a 0.25 mg dose during the randomization visit, at week 4 this will be escalated to a 0.5 mg dose and at week 8 it will be escalated again to a 1.0 mg dose if tolerable by the participant. If the participant cannot tolerate the 0.25 mg dose at randomization or the 0.5 mg dose at week 4 they will be withdrawn from the study.
- Placebo Comparator: PlaceboParticipants in this arm will be given a once weekly, subcutaneous, placebo injection matching the Semaglutide experimental arm in addition to their background metformin monotherapy.
Primary Outcome Measure
Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups [ Time Frame: Week 16 (visit 6) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | - |
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